Catalog Number

EP85345

Brand Name

Uni-Patch

Version/Model Number

EP85345

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

99403e33-727c-40cd-b6e2-840091be26f2

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

90884521168356

Quantity per Package

1200

Contains DI Package

10884521168350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE